California Supreme Court Walks Middle Ground on Warnings Causation but Reaffirms Learned Intermediary Doctrine in Himes

As we reported in April, the United States Court of Appeals for the Ninth Circuit certified a question on California’s Learned Intermediary Doctrine in Himes v. Somatics, LLC, 2022 WL 989469 (9th Cir. Apr. 1, 2022). The California Supreme Court has now decided the issue in a way that walks the middle ground. On the one hand, the court rejected plaintiff’s call for recognizing an exception to the learned intermediary rule and reaffirmed the basic rule that a manufacturer’s duty to warn runs to the prescribing physician. On the other hand, the court ultimately lowered plaintiff’s burden of providing warnings causation. The opinion has clear ramifications not only on dispositive motion and trial practice, but on discovery strategies in prescription drug and medical device cases.

The question before the court was whether a plaintiff is “required to show that a stronger risk warning would have altered the physician’s decision to prescribe the product,” or whether a plaintiff may instead establish causation “by showing that the physician would have communicated the stronger risk warning[ ] to the plaintiff, either in their patient consent disclosures or otherwise, and a prudent person in the patient’s position would have declined the treatment after receiving the stronger risk warning.” (Himes v. Somatics, LLC, 16 Cal.5th 209 (2024).)

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Georgia Court of Appeals Confirms “First Sale” as Used in Statute of Repose Refers to Sale of First Unit of Repeatedly Purchased Products

Georgia’s product liability statute of repose requires actions to be commenced within 10 years of “the date of the first sale for use or consumption” of the product at issue. OCGA § 51-1-11(b)(2) (emphasis added). While the concept of “first sale” is clear and intuitive in the context of a product that may be sold and then later resold, it may be somewhat less clear as applied to a consumable product that is purchased repeatedly over a lengthy period of time. Is the “first sale” of such a product the earliest transaction by which the plaintiff ever obtained the product, or does “first sale” merely refer to the initial purchase of each individual unit of the product as opposed to any subsequent resales? The Georgia Court of Appeals recently clarified that it is the former – “first sale,” for purposes of the statute of repose, refers to the “first sale” of any unit of the product to the plaintiff. Thus, subsequent purchases of a new unit of the product do not come with their own fresh repose periods.

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Loper Bright & Corner Post Review: Supreme Court’s Overturning of Chevron Doctrine Spells Uncertainty for Food Industry Regulations

On June 28, 2024, the U.S. Supreme Court overturned the Chevron doctrine of agency deference in its Loper Bright Enterprises v. Raimondo decision. The doctrine takes its name from a 1984 Supreme Court case, Chevron U.S.A., Inc. v. Natural Resources Defense Council, Inc, 467 U.S. 837 (1984), which announced a bright-line rule governing whether a regulation promulgated by an executive branch agency, like FDA or USDA, was enforceable based on the scope of statutory authority Congress delegated to the agency. Chevron held that if a court concluded that a statute was silent or ambiguous as to an issue (Step One), then the court must defer to an agency’s permissible construction of the statute in the regulations it promulgated (Step Two). In overturning Chevron deference, Loper Bright announced that courts “must exercise their independent judgment in deciding whether an agency has acted within its statutory authority.”

To read the full article, visit the Faegre Drinker website.

Peer Review Can’t Save “Junk Science” from FRE 702 Judicial Gatekeeping – In re: Roundup Court Excludes Expert Whose Opinions Had Been Published in Peer-Reviewed Literature

When tasked with assessing the admissibility of expert testimony under Federal Rule of Evidence 702, courts often cite the so-called Daubert factors as criteria that guide the inquiry.  Among those factors is “whether the [expert’s] theory or technique has been subjected to peer review and publication.”  Daubert v. Merrell Dow Pharms., Inc., 509 U.S. 579 (1993).  The Daubert Court observed that, although publication “is not a sine qua non of admissibility,” peer review “increases the likelihood that substantive flaws in methodology will be detected.”  But peer review is not coterminous with the Rule 702 inquiry that federal courts are called upon to make, especially with the rise of so-called predatory publishing and journals with relaxed (or absent) peer review processes.  As one court recently observed, “a court can’t wave junk science through the Daubert gate simply because it survived some prepublication peer-review process.”  In re: Roundup Products Liability Litigation, 2024 WL 3074376 (N.D. Cal. June 20, 2024).

In In re: Roundup, the plaintiff claimed to have developed non-Hodgkin’s lymphoma (NHL) as a result of using the defendant’s herbicide.  In support of that claim, he offered a single expert on the issue of whether glyphosate, the active ingredient in the herbicide, can cause NHL in humans.  The expert’s opinions were all contained in two peer-reviewed and published articles that the expert had co-authored.  But only one of the two—a 2019 meta-analysis of six epidemiological studies addressing the link between glyphosate and NHL, which had been published before the expert became involved in the litigation—grappled with the available epidemiological evidence.  The defendant attacked that paper on multiple grounds, and the court agreed that it constituted “junk science” with several flaws each independently justifying its exclusion.

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Extended Producer Responsibility (EPR) is Here and It’s Time to Register With a Producer Responsibility Organization (PRO)

As Extended Producer Responsibility (EPR) kicks off across the U.S., manufacturers should be mindful of sustainability claims, especially related to packaging materials and recycling. EPR reporting will generate significant, publicly available data, which could potentially be used in greenwashing claims against covered producers.

To read the full article, visit the Faegre Drinker website.

Northern District of Illinois Holds that Seventh Circuit Precedent is Incompatible with Rule 702 as Amended

In explaining the December 2023 amendments to Federal Rule of Evidence 702, the Advisory Committee called out several ways in which “many courts” had “incorrectly” applied Rule 702 and failed to adequately discharge their duty as gatekeepers with regard to expert witness testimony.  The import of those comments is that existing precedent on Rule 702 may be “incorrect” and must be re-examined.

A case pending in the Northern District of Illinois serves as a fine illustration of how this re-examination should work in practice.  In West v. Home Depot U.S.A., Inc., 2024 WL 1834112 (N.D. Ill. Apr. 26, 2024), the plaintiff alleged that she was injured when portions of a store display fell on her.  She offered a trio of experts to opine that her claimed injuries had been caused by the incident, but none of them “were aware of, let alone reviewed, [her] highly salient medical history prior to issuing their causation opinions.”  Rather, they were treating physicians who based their opinions solely on their post-incident treatment of the plaintiff.

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